2012 Top Ten list for new drug approvals

The US Food and Drug Administration recently announced (pdf) that it had cleared 35 new drugs during 2012, of which 31 were novel therapies. This is in addition to the literally hundreds of approvals for changes in already approved drugs for changes in packaging, manufacturing, and dozens of other reasons.

In no particular order, here are the top 10 most interesting of the approvals based on my subjective viewpoint, which includes innovativeness, seriousness of disease, and other random factors. In others, no different in importance than all those end-of-year top 10 movie lists. So here we go:

AUBAGIO (teriflunomide). Manufactured by Sanofi-Aventis, it is indicated relapsing forms of multiple sclerosis (MS). According to research, eriflunomide inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. Furthermore, it may decrease the risk of infections compared to chemotherapy-like drugs because of its more-limited effects on the immune system.

STENDRA (avanafil). Manufactured by Vivus Inc, and it is indicated for the treatment of erectile dysfunction (ED). I know, what’s the big deal with another ED drug? Well, this one has fewer side effects and is faster working. And despite the beliefs that people take them just for fun, for those men with reduced blood flow as a result of diabetes, vascular disease, and other real medical conditions, ED medications can improve the quality of life and can reduce depression.

STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir). Manufactured by Gilead Sciences, it is indicated for treatment of HIV infections and AIDS. The cobicistat component increases the effectiveness of the combination by inhibiting liver enzymes that metabolize the other components.

These new drugs (out of many that got approved) save lives. They make patient’s quality of life higher. And the FDA along with the pharmaceutical companies work to bring out new pharmaceuticals for rare diseases, or those diseases that do not get a lot of research effort, to help people. So whenever I hear that oft-repeated myth that “Big Pharma never helps anyone”, let’s show them 2012. Or 2011. Or 1998. Or whatever year you want over the past 20.

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Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!